Standard Operating Procedure for Use of Barcode Scanning for Raw Material Identification at Receiving
| Department | Warehouse / Quality Assurance / Quality Control / Procurement |
|---|---|
| SOP No. | SOP/RM/052/2025 |
| Supersedes | SOP/RM/052/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) defines the process for using barcode scanning technology for the identification of raw materials at the receiving stage. It ensures accurate, efficient, and traceable identification of materials, minimizing errors and enhancing compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw materials received at the facility, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, that are equipped with barcode labels for identification. It covers procedures for scanning, verifying, documenting, and resolving barcode-related issues during receipt.
3. Responsibilities
- Warehouse Personnel: Perform barcode scanning during receipt, verify material identity, and document scanning results.
- Quality Assurance (QA): Review barcode scanning logs and approve materials based on verification results.
- Quality Control (QC): Conduct further testing if barcode verification fails or discrepancies arise.
- Procurement Department: Ensure suppliers provide correct barcode information and resolve discrepancies.
4. Accountability
The Warehouse Manager is responsible for the implementation and proper use of barcode scanning systems. The QA Manager holds authority to approve or reject materials based on barcode verification. The Procurement Manager ensures suppliers comply with barcode labeling requirements, and the QC Manager addresses any discrepancies detected through barcode scanning.
5. Procedure
5.1 Pre-Receipt Preparations
-
Supplier Barcode Requirements:
- Procurement ensures suppliers provide barcode labels on all raw materials, including batch number, material name, and manufacturing/expiry dates.
- Suppliers must submit barcode specifications and formats prior to delivery.
-
System Preparation:
- Warehouse personnel ensure barcode scanners are fully charged and operational.
- Verify that the barcode scanning software is synchronized with the inventory management system.
5.2 Barcode Scanning at Receipt
-
Initial Material Scanning:
- Upon delivery, Warehouse personnel scan the barcode on each material container.
- Verify that scanned data matches the information in the delivery note and purchase order (PO).
- Document scanning details in the Barcode Scanning Log (Annexure-1).
-
Handling Unreadable Barcodes:
- If a barcode is unreadable, manually verify the material information and record the incident in the Barcode Discrepancy Report (Annexure-2).
- Report the issue to QA and Procurement for further investigation.
5.3 Post-Scanning Verification
-
Data Verification:
- Ensure that scanned information matches the specifications in the system, including batch number, material name, and quantity.
- Document verified materials in the Material Receipt Log (Annexure-3).
-
QA Review and Approval:
- QA reviews the barcode scanning log and approves the material for further processing.
- Non-compliant materials are quarantined, and discrepancies are investigated.
5.4 Handling Barcode Discrepancies
-
Identification of Discrepancies:
- Discrepancies in barcode data (e.g., mismatched batch numbers, missing information) are logged in the Barcode Discrepancy Report (Annexure-2).
- Warehouse notifies QA and Procurement for resolution.
-
Corrective Actions:
- Procurement contacts the supplier for clarification or replacement of barcode labels.
- QA ensures that corrective actions are implemented before final material approval or rejection.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
- QC: Quality Control
- PO: Purchase Order
7. Documents
- Barcode Scanning Log (Annexure-1)
- Barcode Discrepancy Report (Annexure-2)
- Material Receipt Log (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- EU Guidelines on Good Distribution Practices (GDP)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Barcode Scanning Log
| Date | Material Name | Batch Number | Scanned Barcode Data | Verified By | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | API-X | X-2025-001 | API-X-2025-001 | John Doe | Data Verified |
| 01/02/2025 | Excipient-Y | Y-2025-002 | Excipient-Y-2025-002 | Jane Smith | Data Verified |
Annexure-2: Barcode Discrepancy Report
| Date | Material Name | Batch Number | Discrepancy Description | Reported By | Corrective Action | Status |
|---|---|---|---|---|---|---|
| 01/02/2025 | API-X | X-2025-001 | Unreadable Barcode | John Doe | Supplier Notified, New Label Issued | Closed |
Annexure-3: Material Receipt Log
| Date | Material Name | Batch Number | Quantity Received | Scanned Barcode Data | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | API-X | X-2025-001 | 100 kg | API-X-2025-001 | QA Manager |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Added Barcode Discrepancy Handling Procedures | Standardization | QA Head |